FDA.reportPublic FDA data

Bite Fork Adapter UN

Primary DI
B915019604200
Brand
Bite Fork Adapter UN
Company
zebris MEDICAL GmbH
Model
01960420
Device description
The Bite Fork Adapter UN is an accessory of the JMA-Optic facebowand used for connecting the lower jaw sensor to a bite fork.
Published
2023-07-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
NFSDevice, Jaw Tracking, For Monitoring Jaw Positions

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NFSDevice, Jaw Tracking, For Monitoring Jaw PositionsDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B915019604200PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
FacebowA caliper-like dynamic dental instrument intended for use in a dental diagnostic procedure to record the relative position of the mandible to the temporomandibular joints (TMJs) and/or to record the spatial relationship between the maxilla and mandible. This determination is intended for use in placing models of the upper and lower jaws into an articulator and/or in assessing a range of movements in the TMJs. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-20 Degrees Celsius70 Degrees Celsius

Regulatory Flags#

DUNS number
328971791
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B915015705201Inductive Charger Tizian JMA-Optic01570520NA2023-10-04
B915015705401Inductive Charger ARCUSdigma III01570540NA2023-10-04
B915011700230Tizian JMA Optic USB01170023NA2023-07-20
B915011700410ARCUSdigma 3 USB01170041NA2023-07-20
B915015700231Tizian JMA Optic USB01570023NA2023-07-20
B915015700411ARCUSdigma 3 USB01570041NA2023-07-20
B915011700210Tizian JMA Optic01170021NA2021-02-18
B915011700400ARCUSdigma 301170040NA2021-02-18
B915015700211Tizian JMA Optic01570021NA2021-02-18
B915015700401ARCUSdigma 301570040NA2021-02-18
B915015705101Inductive Charger JMA-Optic01570510NA2023-10-04
B915015705501Inductive Charger zebris for ceramill01570550NA2023-10-04
B915015705701Inductive Charger PlaneAnalyser II01570570NA2023-10-04
B915012430050FDM-SX01243005NA2023-08-11
B915012430100FDM-S01243010NA2023-08-11
B915012430150FDM-1.501243015NA2023-08-11
B915012430200FDM-201243020NA2023-08-11
B915012430300FDM-301243030NA2023-08-11
B915015430051FDM-SX System01543005NA2023-08-11
B915015430101FDM-S System01543010NA2023-08-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06970163085968SHINING 3D®Shining 3D Tech Co., Ltd.NFS2025-05-23
06970163087672SHINING 3D®Shining 3D Tech Co., Ltd.NFS2025-05-23
06970163084213SHINING 3D®Shining 3D Tech Co., Ltd.NFS2025-03-15
06970163081489MARATHON®Shining 3D Tech Co., Ltd.NFS2023-10-13
B915015705101Inductive Charger JMA-Opticzebris MEDICAL GmbHNFS2023-10-04
B915015705201Inductive Charger Tizian JMA-Opticzebris MEDICAL GmbHNFS2023-10-04
B915015705401Inductive Charger ARCUSdigma IIIzebris MEDICAL GmbHNFS2023-10-04
B915015705501Inductive Charger zebris for ceramillzebris MEDICAL GmbHNFS2023-10-04
B915015705701Inductive Charger PlaneAnalyser IIzebris MEDICAL GmbHNFS2023-10-04
06970163081229Opera System®Shining 3D Tech Co., Ltd.NFS2023-08-23
B915015700521zebris for ceramill USB-Lzebris MEDICAL GmbHNFS2023-07-24
B915011700230Tizian JMA Optic USBzebris MEDICAL GmbHNFS2023-07-20
B915011700410ARCUSdigma 3 USBzebris MEDICAL GmbHNFS2023-07-20
B915011700510zebris for ceramill USBzebris MEDICAL GmbHNFS2023-07-20
B915011700720PlaneAnalyser II USBzebris MEDICAL GmbHNFS2023-07-20
B915015700131JMA Optic USB-Lzebris MEDICAL GmbHNFS2023-07-20
B915015700231Tizian JMA Optic USBzebris MEDICAL GmbHNFS2023-07-20
B915015700411ARCUSdigma 3 USBzebris MEDICAL GmbHNFS2023-07-20
B915015700511zebris for ceramill USBzebris MEDICAL GmbHNFS2023-07-20
B915015700721PlaneAnalyser II USBzebris MEDICAL GmbHNFS2023-07-20
B915019602500Para-occlusal Attachment with Lip Archzebris MEDICAL GmbHNFS2023-07-13
B915019602510Para-occlusal Attachment with Lip Arch AGzebris MEDICAL GmbHNFS2023-07-13
B915019602550Para-occlusal Attachment with Support Surfacezebris MEDICAL GmbHNFS2023-07-13
B915019602560Para-occlusal Attachment with Support Surface AGzebris MEDICAL GmbHNFS2023-07-13
B915019602600Para-occlusal Attachmentzebris MEDICAL GmbHNFS2023-07-13
B915019602800Occlusal Attachment UNzebris MEDICAL GmbHNFS2023-07-13
B915019603300Bite Fork Type SI / Fusion Bitezebris MEDICAL GmbHNFS2023-07-13
B915019603410Bite Fork PS1 zebris MEDICAL GmbHNFS2023-07-13
B915019603600Bite Fork UN zebris MEDICAL GmbHNFS2023-07-13
B915019604000Bite Fork Adapter / Fusion Bite Adapterzebris MEDICAL GmbHNFS2023-07-13